Open Label Clinical Trial of Intravenous Crotoxin Part 3

Launched by CELTIC BIOTECH LTD · Nov 28, 2011

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Crotoxin, which is given through an intravenous (IV) line, to see if it can help cancer patients tolerate higher doses without experiencing unpleasant side effects. The main goal is to find out if patients can handle this treatment better than previous methods that used injections into the muscle, which sometimes caused issues. This trial is specifically looking at adult patients with advanced solid tumors who haven't responded to standard treatments or have no other options available.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of certain types of cancer, excluding specific cancers like basal cell carcinoma and stomach cancer. They should be in good overall health, meaning they can move around without assistance and have normal blood counts. Participants will need to have recently evaluated their tumors and must not have had any recent major surgeries or significant weight loss. Throughout the study, they will receive treatment and have regular check-ins to monitor their health. It's important to note that participants must live reasonably close to the hospital and have access to a phone in case of emergencies. If you or someone you know is interested in this trial, it's crucial to discuss it with a doctor for more personalized information.

Gender

ALL

Eligibility criteria

• Subjects will:
• • 1. Be adult patients with histologically confirmed advanced solid tumors (excluding basal cell, colon, pancreatic and stomach cancers) who have progressed despite standard therapy, or for whom no standard therapy exists.
• • 2. Have an ambulatory PS (ECOG 0-1).
• • 3. Have tumor evaluation made within 28 days before study drug administration
• • 4. Have completed radiotherapy or chemotherapy or any other anticancer therapy (including experimental therapy) more than 4 weeks prior to enrolment into the trial and must have recovered from all acute side effects of these treatments
• • 5. Have a life expectancy greater than 3 months
• • 6. Have an age ≥ 18 years
• • 7. Have normal marrow function with the following haematological parameters normal; Hb ≥10g/dl, WBC ≥4.0 x10E9/L, neutrophil count ≥ 2.0 x 10E9/L and platelets ≥100 x10E9 /L
• • 8. Have no medically significant impairment of cardiac or respiratory functions\<
• • 9. Have adequate hepatic function with Total bilirubin 1.5 x N and Transaminases \< 2.5 x N (\< 5 x N in case of liver metastasis).
• • 10. Have no history of prior severe allergic reactions to venoms
• • 11. Have Creatinine clearance \> 50 mL/min.
• • 12. Be on stable doses of any drugs which may affect hepatic drug metabolism or renal drug excretion (e.g.--non-steroidal anti-inflammatory drugs, barbiturates, narcotic analgesics, probenecid). Such drugs should not be initiated while the patient is participating in this study.
• • 13. Not be pregnant or planning to become pregnant
• • 14. Not known to have brain metastases or leptomeningeal involvement. CT-scan or MRI is not required to rule this out unless there is clinical suspicion of central nervous system involvement
• • 15. Not have pleural effusion/ ascites, cystic lesions or bone metastases, as the only assessable lesions
• • 16. Not have a history of other malignancies, except for patients with a cancer free interval of \> 5 years after treatment completion, patients with prior history of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
• • 17. Not have had recent major surgery (within 21 days).
• • 18. Not have a recent history of weight loss \> 10% of current body weight.
• • 19. Not have serious intermittent medical illnesses which would interfere with the ability of the patient to carry out the treatment program.
• • 20. Not be on chronic steroid medication (\> 20mg/day)
• • 21. Not have primary or paraneoplastic myasthenia gravis
• • 22. Be free of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
• • 23. Will agree to participate in the study prior to starting with any specific study procedure, after having signed written informed consent.
• • 24. Be patients of childbearing age willing to use contraceptive for the duration of the study
• • 25. Not live alone and live no further than approximately 30 km away from the hospital, and for the study duration have continuous access to the use of mobile telephone in case of medical emergency